Manager, Quality Assurance (GCP / Early Phase) - $10k Sign On Bonus!

Location: San Antonio, Texas, United States

Apply Refer a Friend

Requisition Number: 2661

Position Title: Manager, Quality Assurance

External Description:

Who we are 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.  

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. 

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.     

What you will do 

 SUMMARY: To have in-depth experience and working knowledge in appropriate GxP compliance and other applicable regulations in order to conduct various types of audits to assess Worldwide Clinical Trials processes and procedures, applicable regulations and Sponsor SOPs, when necessary. Provides guidance on regulatory compliance to internal clients. Provides direction and coordination of project activities related to assigned areas in liaison with QA management. Manages a group of professional audit specialists, provides direction, guidance coaching, training and motivation to internal staff and external associates.  The Manager, Quality Assurance (QA) works under the general supervision and guidance of the Senior (Sr.) Manager, QA, Director, QA or Sr. Director, QA and may directly supervise the Associate QA Auditor, QA Auditor, Sr. QA Auditor.

  • Always representing WCT in a professional manner (verbal, written, and in appearance) when interacting with sponsors, volunteers, outside vendors, and fellow employees.
  • Coordinates and performs audits and completes written reports for each audit assigned.
  • Manages all audits for early phase/ Phase I clinical trials, assigns projects, and provides QA Management with current status
  • Monitors regulatory agency and industry compliance standards and trends to assure an appropriate Company compliance program.
  • Identify improvements that enhance the quality and manages corrective and preventive action plans (CAPAs) to resolve potential quality issues
  • Assists with training and mentoring of the audit team on GCP/GLP, SOP’s, and other related training

What you will bring to the role 

  • Sound knowledge of GxP (specifically GCP) regulations and requirements
  • Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events.
  • Ability to use logical inferences to understand the “big picture” and long term implications of these issues.
  • Understanding of FDA Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature (ERES).
  • Ability to interact professionally, promote team work, and to work independently or in teams.

Your experience 

  • Bachelor’s degree or higher in life science or equivalent experience gained by working in a relevant area (clinical setting, laboratory, etc.).
  • Minimum of 2 years of management experience
  • Minimum 5 years’ experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, of which 3 are in quality assurance auditing.  

Why Worldwide  

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.    

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers! 

#IND-SH1

#LI-SH1

City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Manager, Quality Assurance (GCP / Early Phase) - $10k Sign On Bonus!

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: San Antonio, Texas US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

 Worldwide Clinical Trials does not accept unsolicited resumes from 3rd party vendors

CONNECT WITH US

                



© Worldwide Clinical Trials 2021

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.